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U.S. Department of Health and Human Services

Class 2 Device Recall Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.

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  Class 2 Device Recall Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. see related information
Date Initiated by Firm March 10, 2017
Create Date April 11, 2017
Recall Status1 Terminated 3 on March 12, 2018
Recall Number Z-1780-2017
Recall Event ID 76805
510(K)Number K150087  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Code Information Mfg. Lot or Serial # System ID 000955S60 VS60000955 000973S70 VS70000973 000974S70 VS7000974 000997S70 VS70000997 001022S70 VS70001022 001020S70 VS70001020 000941S70 VS70000941 000951S70 VS70000951 000982S70 VS70000982 000981S70 VS70000981 000994S70 VS70000994 000976S70 VS70R000976 000993S70 VS70000993 000980S70 VS70000980 000998S70 VS70R000998 000996S70 VS70000996 001005S70 VS70001005 001010S70 VS70001010 001007S70 VS70001007 001008S70 VS70001008 001021S70 VS70001021 001029S70 VS70001029 001040S60 VS60001040 001052S70 VS70001052 001048S70 VS70001048 001051S70 VS70001051 001066S60 VS60001066 001054S60 VS60001054 001059S70 VS70001059 001064S70 VS70001064 001067S70 VS70001067 001062S70 VS70001062 001047S70 VS70001047 001050S70 VS70001050 001073S70 VS70001073 001076S70 VS70001076 001078S70 VS70001078 001074S70 VS70001074 001129S70 VS70001129 001120S60 VS6001120 001137S70 VS70001137 001157S70 VS70001157 001230S60 VS60001230 001246S60 VS60001246 001253S60 VS6001253 001336S60 VS6001336 001345S60 VS60001345 000948S70 VS70000948 000995S70 VS70000995 001053S70 VS70001053 001055S60 VS60001055 001056S70 VS70001056 001039S70 VS70001039 001060S70 VS70001060 001069S70 VS70001069 001112S60 VS60001112 001128S70 VS70001128 001138S70 VS70001138 001163S70 VS70001163 001165S70 VS70001165 001238S60 Not Available 001256S60 VS60001256 001003S70 VS70001003 001332S60 VS60001332 001347S60 VS60001347 001329S60 VS60001329 001310S60 Not Available 001250S70 Not Available 000969S70 VS70969S70 000971S70 00123ULT34 000966S70 00111ULT15 001023S70 00111ULT14 001046S70 00982ULT02 001036S70 00506ULT19 001072S70 20347ULT03 001117S60 00058ULT15 001175S70 00115ULT16 001298S70 00149ULT44 001340S70 00004ULT17 001150S70 00199ULT36 001264S70 00199ULT39 001260S70 00199ULT37 001254S70 00199ULT36 000978S70 00459ULT17 001322S70 00624ULT30 001307S70 00136ULT11 001309S70 21367ULT01 001354S60 00195ULT26 001337S70 00296ULT13 001002S70 0853380377 001182S70 529040US21 001325S70 Not Available 001114S70 A004US71 000960S70 O009US94 001113S70 A042US13 001140S70 BD003US38 001171S70 A042US14 001190S70 MPX43159 001174S60 Not Available 001146S60 GON4457540 001172S60 GON4422820 001143S70 C99999284 1104S70N ZA2785US01 1106S70N ZA2790US01 1103S70N ZA2820US01 1198S60N ZA2945US01 592S70N ZA2820US02 1107S70N Not Available 001417S60 GON4445496 001400S70 6073UL0319 1366S60N SA2517US01 1194S60N SA2511US01  001242S70 RU7950US05 001231S70 RU1173US06 001257S70 RU6396US07 001393S70 600152US07 001042S60 Not Available 001034S60 RO4186US12 001151S60 RE1110US01 1105S60N QA1046US02 001115S60 PER46108 001167S70 PL1698US08 001080S70 PL7475US03 001215S70 PL1334US09 001192S60 1557UL0338 000977S70 VS70977S70 1368S60N GON4436983 001173S70 Not Available 001279S70 Not Available 001099S70 Not Available 001179S60 Not Available 001234S60 Not Available 001224S60 Not Available 001324S60 Not Available 1200S70N Not Available 000953S60 NO4005U120 000970S70 NO4031US24 001000S70 NO4068US85 001169S70 NO4088US60 001218S60 NO4202US03 001316S60 NO4442US01 001221S60 8315344197 001012S60 0850372938 001093S70 0850372991 001108S70 0850372993 001098S70 0850372992 001265S70 0850373034 001284S60 0850373074 001311S60 0850373460 001312S70 0850373120 001313S70 0850373117 001326S70 0850373109 1195S60N JO4041US03 1196S70N JO4041US04 000944S60 QEA060 001011S60 QEA061 001014S60 QEA062 001016S60 QEA064 001015S60 QE0063 001085S60 QE0065 001092S60 QE0066 001203S70 QE0067 001239S60 UX9652 001247S60 QE0069 001233S60 QE0073 001248S60 QE0075 001245S60 QE0074 001244S70 QE0071 001249S70 QE0072 001227S70 QE0070 001261S60 QE0076 001286S70 QE0078 001275S70 QE0077 001282S60 QE0080 001258S70 QE0079 001304S70 QE0084 001341S60 QE0083 001328S60 QE0082 001299S60 QE0081 001292S70 Not Available 001177S70 A470456401 001369S70 A5935902 001394S70 A5289906 000029S70 A5113139 001033S70 Not Applicable 907S60N IR2197US01 1367S60N 5512UL0905 001152S70 083038820115216 001152S70 083038820115216 001281S70 083038800060616 001213S70 083038800148317/083038801699017 001327S70 083038804905016 986S70N 083038604420116 001083S70 HUDUS0525 001084S70 HUDUS0527 001095S70 HUDUS0526 001094S60 HUDUS0123 001243S70 HUDUS0420 001241S70 HUDUS0421 001396S70 HUDUS0489 001387S60 HUDUS0183 001412S60 HUDUS0184 001407S70 HUDUS0182 001131S70 HUDUS0354 001330S70 0828380483 001097S60 GP1112US01 001216S60 H2105US04 001216S60 H2105US04 001305S70 H22421US02 001270S70 Not Available 001331S70 Not Available 000975S70 142541U076 001018S60 110012U092 001025S60 110012U093 001028S60 TP1098U001 001043S60 110012U090 001086S60 4683234U01 001090S70 4633351U01 001135S60 802641U005 001136S60 2431497U02 001142S70 110826U019 001160S60 1771688U04 001291S60 149712U007 001306S60 2551720U03 001252S60 145424U104 001274S60 104462U006 001333S70 TP9048U024 001350S70 151176U012 001395S70 110916U011 001403S60 110459U036 001164S60 148015U004 001166S60 147739U005 001259S70 106018U004 001263S70 2103790U24 001024S60 3650585U02 001026S60 1279706U02 001049S60 356393U005 001041S60 138050U008 001070S70 4209769U01 001013S70 120139U054 001081S60 1702988U05 001087S60 4697185U01 001071S70 143083U004 001089S70 4678439U01 001088S70 112132U011 001100S70 141114U056 001096S70 138792U029 001110S70 100007U027 001119S70 138251U024 001130S70 110910U050 001134S70 145905U014 001121S60 148265U004 001132S60 122009U079 001133S70 3686201U04 001159S60 4731568U01 001161S70 110173U024 001158S60 124001U002 001154S70 1220242U05 001149S70 TP0575US04 001162S70 4678439U02 001214S60 4731568U01 001212S60 2088742U03 001236S60 800524U005 001297S60 4208447U03 001294S60 140141U034 001301S60 110596U013 001251S70 145766U006 001288S70 145766U007 001293S70 1898210U03 001295S60 149847U024 001303S60 TP2467U039 001289S60 1893276U01 001302S60 4700381U01 001296S60 4208447U02 001318S60 104096U004 001300S60 4701723U03 001323S60 105843U003 001321S60 4701723U01 001365S70 1951144U28 001374S70 110997U013 001356S70 110146U008 001383S70 1951144U27 001397S70 122006U085 001382S70 4695527U01 001401S70 110855U016 001402S60 110632U004 001406S60 4762251U01 001408S60 4762250U01 001398S60 145430U007 001413S60 804380U006 001418S70 110499U032 001201S60 4711307U01 000934S70 110162U025 000963S70 145924U004 001272S70 120053U024 001268S70 2017571U33 000947S60 Not Available 000946S60 Not Available 000956S60 Not Available 000958S60 Not Available 001148S60 GON4423471 001183S60 U437830301 001185S60 U437830302 001220S60 US30003301 001222S70 U464557301 001315S60 US31001301 001314S60 U470803601 000937S60 US78044607 001038S70 Not Applicable 000957S60 U287989802 000961S60 USM4198037 000959S60 USM4198036 000967S60 US29066206 000968S60 US88657318 001031S70 US26187813 001035S70 USM2505607 001109S60 US50272418 001127S70 US88657317 001126S70 USM4177308 001111S60 US50272417 001144S70 USN4165408 001147S70 U151064604 001153S70 U151064605 001189S60 USM2505317 001186S70 U276410807 001178S70 USN4165409 001204S70 USM4166011 001168S60 001168S60 001219S70 USM3183518 001228S70 USM4329426 001232S60 USM4477110 001240S60 USN4213405 001225S70 U243851504 001271S60 USM4497217 001267S70 USM2607019 001278S70 USM2607020 001280S70 USM4482808 001283S70 US67382203 001287S60 US41892022 001290S60 U282272013 001392S70 USN4165410 001379S70 USM4490608 001376S70 USM4199322 001364S70 USM4497218 001391S60 U222842502 001421S70 US78034314 001191S60 U239390103 001206S60 UN88016207 000962S60 US98957510 001141S60 US60815807 000938S70 US29072605 000933S70 GON4457410 000939S60 Not Available 001217S70 FI1063US29 001223S70 FI1032US07 001229S70 FI1063US28 000979S70 DK1022US54 000954S70 Not Available 001255S70 DK1090US21 001320S70 DK1058US42 001262S70 DK1022US58 001027S60 CZ6403US02 001317S70 CZ6001US09 000999S70 416778VS70 001037S70 416494VS70 001335S70 416446VS70 001370S70 Not Available 001202S60 VS601202S60 000972S70 030042US13 001102S70 030392US15 001235S60 030419US12 001237S60 030419US13 001386S70 030392US17 001030S70 947667US02 001032S60 568080US02 000753S70 100029US11 001205S70 220166US25 001208S70 190105US28 001416S70 701697US01 001207S60 190171US13 001170S70 701708US01 001388S60 Not Available 001385S70 Not Available 001410S70 Not Available 001226S70 AH1912US32 001273S70 AH5045US11 000952S70 83150625712 001017S70 83151375114 001123S70 83152818712 001180S70 83152648280 001277S70 83154415380 001269S70 83153232163 001276S70 83154414988 001285S70 83154415943 001101S70 Not Available 001193S60 Not Available 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
Manufacturer Reason
for Recall
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
FDA Determined
Cause 2
Software design
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology. The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 396 (67 US; 329 OUS)
Distribution United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India, Hungary, Hong Kong, Guatemala, Greece, Great Britain, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic, Croatia, Colombia, Chile, Canada, Bulgaria, Brunei Darussalam, Brazil, Belgium, Austria, Australia, Argentina, Vietnam. Uruguay, Taiwan, Slovakia, Singapore, Reunion, Qatar, Panama, Pakistan, Jordan, Indonesia, Guadeloupe, Czech Republic
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GE VINGMED ULTRASOUND AS